EPIVIR Drug Patent Profile

Which patents cover Epivir, and when can generic versions of Epivir launch?

Epivir is a drug marketed by Viiv Hlthcare and Glaxosmithkline and is included in four NDAs.

The generic ingredient in EPIVIR is lamivudine. There are twenty-nine drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the lamivudine profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Epivir

A generic version of EPIVIR was approved as lamivudine by APOTEX on December 2^nd, 2011.

Summary for EPIVIR

US Patents:	0
Applicants:	2
NDAs:	4
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	146
Clinical Trials:	46
Patent Applications:	2,597
Drug Prices:	Drug price information for EPIVIR
What excipients (inactive ingredients) are in EPIVIR?	EPIVIR excipients list
DailyMed Link:	EPIVIR at DailyMed

See drug prices for EPIVIR

Recent Clinical Trials for EPIVIR

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Roswell Park Cancer Institute	Phase 2
Bess Frost, PhD	Phase 1/Phase 2
Owens Medical Research Foundation	Phase 1/Phase 2

See all EPIVIR clinical trials

Pharmacology for EPIVIR

Drug Class	Hepatitis B Virus Nucleoside Analog Reverse Transcriptase Inhibitor Human Immunodeficiency Virus Nucleoside Analog Reverse Transcriptase Inhibitor
Mechanism of Action	Nucleoside Reverse Transcriptase Inhibitors

US Patents and Regulatory Information for EPIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	AB	RX	Yes	No
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	AB	RX	Yes	Yes
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	AA	RX	Yes	Yes
Glaxosmithkline	EPIVIR-HBV	lamivudine	TABLET;ORAL	021003-001	Dec 8, 1998		DISCN	Yes	No
Glaxosmithkline	EPIVIR-HBV	lamivudine	SOLUTION;ORAL	021004-001	Dec 8, 1998		DISCN	Yes	No

Expired US Patents for EPIVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	6,180,639*PED
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	5,047,407*PED
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	7,119,202*PED
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	5,047,407*PED
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-003	Jun 24, 2002	6,180,639*PED
Viiv Hlthcare	EPIVIR	lamivudine	TABLET;ORAL	020564-001	Nov 17, 1995	5,905,082*PED
Viiv Hlthcare	EPIVIR	lamivudine	SOLUTION;ORAL	020596-001	Nov 17, 1995	6,180,639*PED

EU/EMA Drug Approvals for EPIVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
ViiV Healthcare BV	Epivir	lamivudine	EMEA/H/C/000107 Epivir is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.,	Authorised	no	no	no	1996-08-08
GlaxoSmithKline (Ireland) Limited	Zeffix	lamivudine	EMEA/H/C/000242 Zeffix is indicated for the treatment of chronic hepatitis B in adults with:, , , compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate;, decompensated liver disease in combination with a second agent without cross-resistance to lamivudine., ,	Authorised	no	no	no	1999-07-29
Teva B.V.	Lamivudine Teva Pharma B.V.	lamivudine	EMEA/H/C/001111 Lamivudine Teva Pharma B.V. is indicated as part of antiretroviral combination therapy for the treatment of human-immunodeficiency-virus (HIV)-infected adults and children.	Authorised	yes	no	no	2009-12-10
Teva B.V.	Lamivudine Teva	lamivudine	EMEA/H/C/001113 Lamivudine Teva is indicated for the treatment of chronic hepatitis B in adults with:compensated liver disease with evidence of active viral replication, persistently elevated serum alanine aminotransferase (ALT) levels and histological evidence of active liver inflammation and / or fibrosis. Initiation of lamivudine treatment should only be considered when the use of an alternative antiviral agent with a higher genetic barrier is not available or appropriate (see in section 5.1).	Authorised	yes	no	no	2009-10-23

International Patents for EPIVIR

See the table below for patents covering EPIVIR around the world.

Country	Patent Number	Title	Estimated Expiration
Hungary	9501825
Hungary	T53362
Hungary	900708
Hungary	T73655
Iceland	4268
Japan	3085675
Poland	164785

Supplementary Protection Certificates for EPIVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2924034	2019/021	Ireland		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND TENOFOVIR DISOPROXIL FUMARATE; REGISTRATION NO/DATE: EU/1/18/1333/001 EU/1/18/1333/002 20181122
2924034	2019C/005	Belgium		PRODUCT NAME: DORAVIRINE,DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT IN COMBINATIE MET LAMIVUDINE, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAARZOUT, IN COMBINATIE MET TENOFOVIR OF EEN ESTER DAARVAN, IN HET BIJZONDER EEN DISOPROXIL ESTER, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER EEN FUMARAAT ZOUT; AUTHORISATION NUMBER AND DATE: EU/1/18/1333/001-002 20181126
0382526	96C0035	Belgium		PRODUCT NAME: LAMIVUDINE; NAT. REGISTRATION NO/DATE: EU/1/96/015/001 19960808; FIRST REGISTRATION: CH 53 662 013 19960228
0513917	98C0020	Belgium		PRODUCT NAME: LAMIVUDINE/ZIDOVUDINE; REGISTRATION NO/DATE: EU/1/98/058/001 19980318
0382526	C960025	Netherlands		PRODUCT NAME: LAMIVUDINUM, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AAN- VAARDBAAR ZOUT; REGISTRATION NO/DATE: EU/1/96/015/001 - EU/1/96/015/002 19960808
2924034	CR 2019 00024	Denmark		PRODUCT NAME: DORAVIRINE OR A PHARMACEUTICALLY ACCEPTABLE SALT THEREOF IN COMBINATION WITH LAMIVUDINE AND IN COMBINATION WITH TENOFOVIR DISOPROXIL FUMARATE; REG. NO/DATE: EU/1/18/1333 20181126
3494972	LUC00346	Luxembourg		PRODUCT NAME: DOLUTEGRAVIR OU UN SEL PHARMACEUTIQUEMENT ACCEPTABLE, Y COMPRIS LE DOLUTEGRAVIR SODIQUE, ET LAMIVUDINE; AUTHORISATION NUMBER AND DATE: EU/1/19/1370 20190703

Market Dynamics and Financial Trajectory for EPIVIR (Lamivudine)

Introduction to EPIVIR (Lamivudine)

EPIVIR, known generically as lamivudine, is a crucial antiretroviral medication used in the treatment of HIV and hepatitis B. It belongs to the class of nucleoside reverse transcriptase inhibitors (NRTIs) and has been a cornerstone in the management of these diseases since its approval.

Market Size and Growth

The global HIV drugs market, which includes EPIVIR, has been experiencing steady growth. As of 2022, the global HIV drugs market was valued at $32.8 billion and is projected to reach $51.1 billion by 2032, growing at a CAGR of 4.5% from 2023 to 2032[1].

Key Drivers of Market Growth

Several factors are driving the growth of the market for EPIVIR and other HIV drugs:

Increase in HIV Prevalence

The rise in the number of people living with HIV globally contributes significantly to the demand for antiretroviral therapies like EPIVIR. In 2022, approximately 39 million people worldwide were living with HIV, and 1.3 million new infections were reported[1].

Government Initiatives and Awareness

Government and international organizations' initiatives to raise awareness about HIV diagnosis and management have increased the demand for HIV drugs. This includes programs aimed at early diagnosis, treatment, and prevention of HIV transmission[1].

Advancements in Treatment

The development and approval of new antiretroviral therapies, including combination regimens that often include lamivudine, have improved treatment outcomes. These advancements have led to higher life expectancy and better quality of life for HIV patients, further driving the market[2][4].

Financial Impact of EPIVIR

Cost-Effectiveness

Studies have shown that the introduction of antiretroviral therapies like EPIVIR has been cost-effective. For instance, the use of EPIVIR and the original three protease inhibitors was responsible for a significant drop in mortality rates from 1995 to 1998, with a cost per life-year saved estimated at approximately $22,000[2].

Medicaid Spending

The increased life expectancy of HIV patients due to effective treatments like EPIVIR has led to higher lifetime Medicaid spending. Despite the high cost of these drugs, the overall benefit in terms of extended life and reduced hospital admissions has been significant. For example, lifetime Medicaid spending for the average patient increased by more than $200,000 over a six-year period due to longer treatment durations[2].

Market Segmentation

By Drug Class

EPIVIR falls under the category of multi-class combination drugs, which held the largest share in the HIV drugs market in 2022. This segment is expected to continue growing as combination therapies become more prevalent and effective[1].

By Distribution Channel

Hospital pharmacies have traditionally dominated the distribution of HIV drugs, including EPIVIR. However, online pharmacies are expected to witness the highest CAGR during the forecast period due to convenience, improvements in logistics, and ease of payment options[1].

Regional Market Dynamics

North America

North America, particularly the United States, has been a major market for EPIVIR and other HIV drugs. The region's robust healthcare infrastructure, strong presence of key players like Gilead Sciences, Inc., and high healthcare expenditure contribute to its dominance. The U.S. market is expected to continue driving growth due to ongoing research and development activities and significant government investments in healthcare[1][4].

Asia-Pacific

The Asia-Pacific region is anticipated to grow at the highest rate during the forecast period. Countries like China and India, with large population bases, are driving this growth. The increase in purchasing power and public-private investments in the healthcare sector in these countries are expected to boost the demand for HIV drugs, including EPIVIR[1].

Competition Analysis

The market for HIV drugs, including EPIVIR, is highly competitive with several major players. Companies like AbbVie Inc., Bristol-Myers Squibb Company, Gilead Sciences, Inc., Johnson & Johnson, and Merck & Co., Inc. are key competitors. The competition is driven by advancements in drug development, increased awareness and diagnosis rates, and rising healthcare expenditure. Emerging markets are also gaining importance as companies focus on unmet medical demands in developing economies[1].

Future Outlook

The future of EPIVIR and the broader HIV drugs market looks promising due to several factors:

• Research and Development: Ongoing R&D activities are expected to lead to novel product launches, further expanding the market.
• Patient Advocacy: Increased patient advocacy and support are driving the demand for new and effective HIV treatment options.
• Technological Advancements: Technological developments, including patient-centric approaches, are enhancing market growth and patient outcomes[4].

Key Takeaways

• EPIVIR is a critical component of the global HIV drugs market, which is projected to grow significantly by 2032.
• The market is driven by increasing HIV prevalence, government initiatives, and advancements in antiretroviral therapies.
• The cost-effectiveness of EPIVIR and other antiretroviral drugs has been established, despite high costs.
• North America currently dominates the market, but the Asia-Pacific region is expected to experience the highest growth rate.

FAQs

Q: What is the current market size of the global HIV drugs market? A: The global HIV drugs market was valued at $32.8 billion in 2022[1].

Q: What is the projected growth rate of the global HIV drugs market? A: The market is expected to grow at a CAGR of 4.5% from 2023 to 2032[1].

Q: Which region is expected to witness the highest growth rate in the HIV drugs market? A: The Asia-Pacific region is anticipated to grow at the highest rate during the forecast period[1].

Q: What are the key drivers of the market growth for EPIVIR and other HIV drugs? A: Key drivers include the rise in HIV prevalence, government initiatives, and advancements in antiretroviral therapies[1][4].

Q: How has the introduction of EPIVIR impacted healthcare costs? A: Despite the high cost of EPIVIR, it has been cost-effective, with a cost per life-year saved estimated at approximately $22,000. However, it has led to increased lifetime Medicaid spending due to longer treatment durations[2].